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Catheter, Continuous Flush

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1210
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.1210 Continuous flush catheter

§ 870.1210 Continuous flush catheter.

(a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

(b) Classification. Class II (performance standards).

Catheter, Continuous Flush

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1210
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.1210 Continuous flush catheter

§ 870.1210 Continuous flush catheter.

(a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

(b) Classification. Class II (performance standards).